适用于 -使用体外诱发压力波的碎石设备； -产生集中机械能的碎石设备。 指定 -可用于体外碎石设备的声输出的声明中的可测量参数， -碎石设备产生的压力场的测量和表征方法。

Applies to - lithotripsy equipment using extracorporeally induced pressure waves; - lithotripsy equipment producing focused mechanical energy. Specifies - measurable parameters which could be used in the declaration of the acoustic output of extracorporeal lithotripsy equipment, - methods of measurement and characterization of the pressure field generated by lithotripsy equipment.